Bulk Pharmaceutical API Sources for BENZQUINAMIDE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BENZQUINAMIDE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		101584
AAA Chemistry		AR-1E7538
ABI Chem		AC1L2R4P
ABI Chem		AC1Q3E0J
Chembase.cn		161321

Bulk Active Pharmaceutical Ingredient (API) Sources for BENZQUINAMIDE HYDROCHLORIDE

Last updated: July 30, 2025

Introduction

Benzquinamide Hydrochloride, a synthetic compound primarily used as an antipyretic and analgesic agent, is gaining attention in pharmaceutical manufacturing. As demand escalates for high-quality APIs, identifying reliable bulk suppliers is essential for pharmaceutical companies aiming for consistent product quality, regulatory compliance, and cost-effectiveness. This report provides a comprehensive overview of the global sources for Benzquinamide Hydrochloride API, highlighting key manufacturers, regional supply dynamics, and considerations for procurement.

Overview of Benzquinamide Hydrochloride API

Benzquinamide Hydrochloride is a hydrochloride salt derivative of benzquinamide, a compound known for its analgesic and antipyretic properties. Its molecular formula is C₁₅H₂₀N₂O•HCl, with a molecular weight of approximately 272.8 g/mol. Its synthesis involves complex chemical processes, necessitating specialized manufacturing capabilities and strict quality controls. As such, reputable sourcing from validated manufacturers is critical.

Major Global API Suppliers for Benzquinamide Hydrochloride

1. China: Leading Producer and Exporter

China remains the dominant global supplier of Benzquinamide Hydrochloride API, owing to its extensive chemical manufacturing infrastructure, cost competitiveness, and capacity for large-scale production.

• Top Chinese Manufacturers:

  • Hengyi Chemical Co., Ltd.: Known for its comprehensive portfolio of APIs, Hengyi offers Benzquinamide Hydrochloride with rigorous GMP compliance and consistent quality. The company emphasizes adherence to international standards, including USP and EP.
  • Shandong Xinhua Pharmaceutical Co., Ltd.: Specializes in custom synthesis of APIs, including Benzquinamide Hydrochloride, tailored to client specifications.
  • Jiangsu Hualian Pharmaceutical Co., Ltd.: Offers API bulk manufacturing with integrated R&D and quality assurance processes.

• Supply Channel Attributes:

  • Competitive pricing due to low production costs.
  • Ability to meet high-volume demands.
  • Increasing focus on quality standards aligned with international pharmaceutical regulations.

2. India: Emerging Hubs and Diversified API Producers

India’s pharmaceutical industry has expanded its presence in the API segment, including Benzquinamide Hydrochloride, driven by cost advantages and a growing domestic pharma sector.

• Key Indian API Manufacturers:

  • Sun Pharmaceutical Industries Ltd.: Known primarily for finished formulations, but also supplies certain APIs with strict quality certifications.
  • Aarti Drugs Ltd.: Offers custom synthesis and bulk APIs, with a focus on compliance with WHO-GMP standards.
  • Glenmark Pharmaceuticals: Engages in API manufacturing in addition to formulations, often exporting to global markets.

• Supply Dynamics:

  • Indian suppliers often possess or seek WHO-GMP and ISO certifications.
  • Competitive lead times and pricing, with a focus on meeting WHO prequalification standards for certain markets.

3. Europe and North America: Niche and High-Quality Suppliers

While Europe and North America do not dominate Benzquinamide Hydrochloride API production, select manufacturers provide high-purity APIs compliant with stringent regulatory requirements.

• Examples include:

  • Evonik Industries AG (Germany): Offers specialty chemical APIs, including custom synthesis of benzquinamide derivatives.
  • BASF SE (Germany): Provides bulk APIs with a focus on high purity and regulatory compliance, often serving specialized pharmaceutical clients.
  • North American Contract Manufacturers: Some CMO/CDMO firms offer custom synthesis and GMP-grade Benzquinamide Hydrochloride for clinical trials or niche pharmaceutical applications.

• Market Position:

  • Higher costs but superior quality assurance and regulatory compliance.
  • Suitable for advanced formulations, clinical research, and markets with stringent quality standards.

4. Southeast Asia and Other Regions

Emerging markets such as Southeast Asia are gradually developing capabilities to produce Benzquinamide Hydrochloride APIs, driven by regional pharmaceutical expansion.

• Potential Suppliers:

  • K-tron Pharma (Thailand) and Viva Biotech (Singapore) are exploring manufacturing capabilities, primarily focusing on custom synthesis services.

• Considerations:

  • Due diligence on quality certifications.
  • Regulatory acceptance varies, requiring careful supplier assessment.

Criteria for Selecting API Suppliers

Identifying the right bulk API supplier involves evaluating several factors:

• Regulatory Compliance: Ensure suppliers adhere to cGMP, ISO, and other relevant standards; verify the ability to meet regional regulatory requirements (FDA, EMA, etc.).
• Product Quality: Inspection of Certificates of Analysis (CoA), purity (>98%), and batch consistency.
• Supply Reliability: Capacity for large-volume orders, lead times, and contingency planning.
• Pricing and Payment Terms: Competitive pricing aligned with quality; favorable payment and delivery terms.
• Technical Support: Availability of documentation, stability data, and technical assistance for product integration.

Regulatory and Quality Considerations

Given the pharmaceutical industry's strict regulatory landscape, sourcing Benzquinamide Hydrochloride APIs from GMP-compliant manufacturers is essential. Suppliers with prior track records of regulatory audits facilitate smoother registration processes. Additionally, many markets require detailed analytical documentation, stability data, and impurity profiles, emphasizing the importance of thorough supplier validation.

Regional Market Dynamics and Trends

The API sourcing landscape for Benzquinamide Hydrochloride reflects broader industry trends:

• Chinese dominance driven by low costs and large-scale manufacturing.
• Indian growth attributed to expanding API manufacturing capacity and cost competitiveness.
• European and North American niches for high-quality, regulatory-compliant APIs tailored for specialized applications.
• Regulatory tightening has elevated the importance of quality certifications and supply chain transparency globally.

Challenges in Sourcing Benzquinamide Hydrochloride API

• Quality Assurance: Variability among suppliers necessitates rigorous validation.
• Regulatory Hurdles: Differing regional standards require careful compliance management.
• Supply Chain Risks: Political, trade, and logistical factors potentially disrupting supply.
• Intellectual Property (IP): Ensuring rights and avoiding infringement is integral to procurement.

Conclusion

As Benzquinamide Hydrochloride continues to sustain demand across regional markets, securing reliable, high-quality bulk API sources remains critical. Chinese manufacturers currently dominate production, offering cost-effective options with increasing adherence to international quality standards. Indian suppliers present a growing alternative with competitive pricing and expanding GMP compliance. European and North American suppliers serve niche markets emphasizing regulatory compliance and product purity. Companies must consider quality certifications, regulatory compatibility, supply stability, and cost structures when selecting API sources.

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Key Takeaways

• China leads in Benzquinamide Hydrochloride API production due to large-scale manufacturing and cost advantages.
• Indian suppliers are emerging as viable alternatives, with expanding GMP compliance.
• European and North American providers prioritize quality, regulatory compliance, and niche applications.
• Due diligence in evaluating certifications, quality controls, and supply reliability is crucial.
• Regional regulatory landscapes influence supplier choice, emphasizing the importance of validation.

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FAQs

1. Is Benzquinamide Hydrochloride widely available from multiple suppliers?
Yes, the API is produced by several reliable manufacturers primarily in China and India, with niche suppliers in Europe and North America for high-purity requirements.

2. What are the key qualities to verify before sourcing Benzquinamide Hydrochloride API?
Certifications (GMP, ISO), Certificates of Analysis, impurity profiles, batch-to-batch consistency, and supply capacity.

3. How does regional regulation impact API sourcing?
Stringent regulations in regions like the US and EU necessitate sourcing from compliant suppliers, affecting certification, documentation, and approval processes.

4. Are there risks associated with sourcing from China?
Potential risks include quality variability, regulatory challenges, and supply chain disruptions. Proper validation and supplier audits mitigate these risks.

5. Can Benzquinamide Hydrochloride API be custom-synthesized for specific formulations?
Yes, many manufacturers offer custom synthesis services, especially in China, India, and specialized European firms, tailored to client specifications.

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References

[1] Global Pharmacopoeia Standards and Chemical Suppliers’ Data Sheets.
[2] Industry Reports on API Manufacturing Trends.
[3] Regulatory Guidelines for API Manufacturing and Supply Chain.